Catalog Number

NEC4004

Brand Name

Evo Cortical Electrode

Version/Model Number

Cortical Electrode, 4x4

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GYC

Product Code Name

Electrode, Cortical

Public Device Record Key

eaf5107d-e884-4687-998c-5c3fc95d893f

Public Version Date

September 22, 2021

Public Version Number

3

DI Record Publish Date

November 02, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-